Expert Panel: Access to Multiple Treatment Options Is Needed to Continue the Fight Against HIV

A multidisciplinary panel of HIV experts gathered in October 2016 to discuss the current state of HIV care and develop critical recommendations for Pharmacy and Therapeutics (P&T) committee members to consider when developing policies affecting their member populations who are living with HIV. This paper presents the panelâ€™s discussion, consensus opinion, and conclusions.

*Jeff Dunn was unable to participate in the October panel meeting, but was actively engaged in the development of this article.

Introduction
Tremendous advancement has been made in the treatment of HIV/AIDS from its early days as a deadly epidemic until today, when HIV can be managed as a serious chronic disease.1 Many factors have contributed to the improved management of HIV, but it is the development of modern antiretroviral (ARV) medicines— which enabled individualized, highly effective treatment regimens—that has made the most impact.2

We are now at a point where significantly decreased mortality,3 the chronicity of HIV, and the availability of additional drug combinations are fueling a rising spending trend for ARVs among public and private payers. As a result, formulary decision-makers may be exploring options to contain costs, while increasing access to novel treatments. This panel of experts examined the converging market dynamics impacting the ARV category to help payers address the challenges of HIV population management through a sustainable, US Department of Health & Human Services (DHHS) guidelines-based approach to ARV access. The panel felt this approach was critical since it offers unbiased, evidence-based recommendations that seek to optimize HIV care and outcomes based on individualized treatment goals. They concluded that access to agents across all ARV drug classes is essential to meeting individualized therapeutic needs.
Evolution of the HIV Epidemic to Serious Chronic Disease
The first cases of what would later become known as HIV/AIDS were identified in 1981.1 Shortly after these cases were documented, the disease began to spread at epidemic proportions into the mid-1990s.2 In 1994, it was the leading cause of death in the United States among 25-44 year olds.1

The advent of potent combination ARV therapy followed in 1996 and, since that time, has dramatically reduced HIV-associated morbidity and mortality.

In addition to these well-known benefits, virologic suppression in the setting of ARV treatment has also proven to be highly effective at preventing HIV transmission.4

Today there are 6 major types of ARV drugs classified by the way they interfere with HIV replication. Modern ARV regimens combine 3 active drugs from at least 2 of these classes in order to achieve virologic suppression and minimize the opportunity for resistance to a particular type of ARV.4,5

Along with spurring accelerated medical and pharmaceutical research, the challenges of HIV/ AIDS hastened the adoption of global goals, established by the United Nations (UN), to focus on response efforts. Similar goals have been adopted in the United States within the National HIV/AIDS Strategy (NHAS) and are being adapted to specific population management needs within major cities, such as San Francisco. Referred to as the “90-90-90” goals, they call for: 90% of the HIV population being diagnosed, 90% of diagnosed patients being on treatment, and 90% of those on treatment being virally suppressed.6

While significant progress has been made, these goals have been challenging to achieve in the United States. According to the most recent (2013) Centers for Disease Control (CDC) report, only ~57% of the HIV-diagnosed population is receiving consistent medical care, and only ~55% is virally suppressed—far below the “90-90-90” goals.7

Access to care and treatment is central to fighting HIV. Many US government initiatives focus on ensuring access for people with HIV. For example, Medicare Part D’s designation of ARV drugs as a protected class to ensure access for patients led to many commercial and Medicaid plans adopting similar policies over time.8

The combined public and private effort has achieved substantial progress in the fight against HIV over the last 2 decades, as evidenced by these facts:

In 1987, the median age at death due to HIV infection was ~37 years; by 2013 it had risen to ~50 years3

In 1985 there were ~130,000 new infections reported in the United States9; in 2015 there were ~40,000 new cases reported10

Development of ARVs allowed HIV to be treated, though regimens in the early period were burdensome and associated with serious adverse events. The introduction of newer, more tolerable agents, fixed-dose combinations, and novel strategies for combination ARV delivery, such as ‘boosting’, have led to improvements in the tolerability and durability of regimens.11 In order to encourage further innovation and continue providing effective care and treatment for people living with HIV, panel members reinforced the need for P&T decision- makers to maintain access to ARVs from all of the 6 drug classes consistent with medical guidelines.